[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635880":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":34,"locations":22,"responsibleParty":40,"collaborators":22,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":22,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":22,"enrollmentInfo":52,"targetDuration":22,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":22,"overallStatus":62,"whyStopped":22,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":22},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CsA+EPAG\u002FHPAG+Romiplostim N01","EXPERIMENTAL","CsA 3-5mg\u002Fkg\u002Fd EPAG 50mg\u002Fd or HPAG 7.5mg\u002Fd Romiplostim N01 20µg\u002Fkg, subcutaneously, once a week",[13,14,15],"Drug: Cyclosporine (CsA)","Drug: thrombopoietin receptor agonist (TPO-RA)","Drug: Romiplostim N01",[17,23,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Cyclosporine (CsA)","CsA 3-5mg\u002Fkg\u002Fd, trough concentration 100-200ng\u002Fml",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"thrombopoietin receptor agonist (TPO-RA)","Eltrombopag 50mg\u002Fd, increased by 25mg every two weeks Hetrombopag 7.5mg\u002Fd, increased by 2.5mg every two weeks",[9],[28,29],"Eltrombopag (EPAG)","Hetrombopag (HPAG)",{"type":18,"name":31,"description":32,"armGroupLabels":33,"otherNames":22},"Romiplostim N01","Romiplostim N01 20µg\u002Fkg, subcutaneously, once a week",[9],[35],{"name":36,"role":37,"phone":38,"phoneExt":22,"email":39},"Bing Han","CONTACT","+86 13601059938","hanbing_li@sina.com.cn",{"type":41,"investigatorFullName":36,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Professor","100635880","phase-2-csaepaghpagromiplostim-n01-in-newly-diagnosed-saatd-nsaa-100635880",false,"NCT07558434","CsA+EPAG\u002FHPAG+Romiplostim N01 in Newly-diagnosed SAA\u002FTD-NSAA","Cyclosporine + Eltrombopag\u002FHetrombopag + Romiplostim N01 in the Treatment of Newly-diagnosed Transfusion-dependent Non-severe Aplastic Anemia\u002F Severe Aplastic Anemia","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Diagnosed with aplastic anemia (AA) through routine blood tests, bone marrow puncture, bone marrow biopsy, and exclusion tests, and determined as transfusion-dependent non-severe aplastic anemia (TD-NSAA) or severe aplastic anemia (SAA) according to the Camitta criteria; Platelet \\\u003C 30×10\\^9\u002FL;\n3. Had no HLA-matched donors or was not suitable for first-line allogeneic hematopoietic stem cell transplantation (HSCT);\n4. Not suitable for ATG, due to reasons such as age, complications, and the patient's own wishes;\n5. With baseline liver and kidney functions \\\u003C2 ULN;\n6. ECOG score ≤ 2;\n7. Signed the informed consent;\n\nExclusion Criteria:\n\n1. Had other primary or secondary bone marrow failure (BMF) diseases, such as Fanconi anemia, congenital keratinization disorder, etc.;\n2. With evidence of clonal hematological bone marrow diseases (MDS, AML) in cytogenetics;\n3. PNH clone ≥ 50%;\n4. Received HSCT before enrollment;\n5. Previously used immunosuppressive treatments such as ATG, CsA, TPO receptor agonists (TPO-RAs);\n6. Allergic or intolerant to romiplostim N01, eltrombopag, hetrombopag, or CsA;\n7. Pregnant or lactating patients;\n8. Severe bleeding or infection that cannot be controlled by standard treatment;\n9. History of arterial or venous thrombosis;\n10. Complicated with malignant tumors;\n11. Participated in other clinical trials within 3 months;\n12. Patients considered not suitable to participate in this study by the investigator.","ALL","18 Years",{"count":53,"type":54},43,"ESTIMATED","INTERVENTIONAL",[57],"PHASE2","This study aimed to explore the efficacy and safety of cyclosporine (CsA)\n\n+eltrombopag (EPAG)\u002Fhetrombopag (HPAG)+romiplostim N01 in the treatment of newly-diagnosed transfusion-dependent aplastic anemia (TD-NSAA) and severe aplastic anemia (SAA)",[60,61],"Severe Aplastic Anemia (SAA)","Transfusion-dependent Non-severe Aplastic Anemia","NOT_YET_RECRUITING","2026-04-23",{"date":65,"type":66},"2026-04-30","ACTUAL",{"date":68,"type":54},"2026-04",{"date":70,"type":54},"2029-12",{"name":5,"class":6}]